510(k) · Cleared
ClearedEmg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eco Medi Glove Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Oct 7, 2014 as substantially equivalent to K110921 (Cardinal Health, Inc., 2011) after a 112-day review. Its family tree reaches back 2 generations to 2002. 6 later devices descend from it.
- Decided
- Oct 7, 2014
- Review
- 112 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022765 (2002). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- 1 generation backK110921 Nitrile Powder-Free Examination Gloves Tested for Use with…Cardinal Health, Inc. · 2011
- This deviceK141623 Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug…Eco Medi Glove Sdn. Bhd. · 2014
- Descendant · cites it directly · 3 of its ownK152542 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis…Riverstone Resources Sdn Bhd · 2015
- Descendant · 2 generations on · 1 of its ownK181066 Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis…Eco Medi Glove Sdn. Bhd. · 2018
- Descendant · 3 generations on · 0 of its ownK233560 Powder Free Nitrile Examination Glove Blue with Low Dermatitis…Eco Medi Glove Sdn. Bhd. · 2024
- Descendant · 2 generations on · 0 of its ownK193121 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential…Eco Medi Glove Sdn. Bhd. · 2020
- Descendant · cites it directly · 0 of its ownK161944 Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue…Shandong Baisheng Medical Products Co., Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K152542Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and…Riverstone Resources Sdn Bhd · 2015 · cites it directly3descendants
- K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested…Eco Medi Glove Sdn. Bhd. · 2018 · 2 generations on1descendant
- K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested…Eco Medi Glove Sdn. Bhd. · 2024 · 3 generations on0descendants
- K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with…Eco Medi Glove Sdn. Bhd. · 2020 · 2 generations on0descendants
- K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for…Shandong Baisheng Medical Products Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| −1 | K110921 | Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs | Cardinal Health, Inc. | 2011 | — |
| 0 (this device) | K141623 | Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim | Eco Medi Glove Sdn. Bhd. | 2014 | — |
| +1 | K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential… | Riverstone Resources Sdn Bhd | 2015 | — |
| +2 | K181066 | Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and… | Eco Medi Glove Sdn. Bhd. | 2018 | — |
| +3 | K233560 | Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential… | Eco Medi Glove Sdn. Bhd. | 2024 | — |
| +2 | K193121 | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and… | Eco Medi Glove Sdn. Bhd. | 2020 | — |
| +1 | K161944 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and… | Shandong Baisheng Medical Products Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZA device
- #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110921 | Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy DrugsSummary page 6…with tested for use with Chemotherapy Drugs, Powder Free,LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K110921, Cornflower Powder Free Exam glove tested for use with Chemotherapy Drugs (Non sterile) . 5.0 Device Description… | 2011 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and… | 2015 | 3 |
| K161944 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for… | 2016 | 0 |
| K161473 | Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152542 (Riverstone Resources Sdn Bhd, 2015) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drugs Chemotherapy Drug and concentration Minimum…
Read the full statement (146 words)
A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs
In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drugs
Chemotherapy Drug and concentration Minimum Breakthrough detection time in Minutes,0.01pg/cm?*/minute
)Carmustine (BCNU) (3.3mg/ml) 1.3 minutes
2)Cyclophosphamide (20mg/ml) > 240 minutes
3)Cytarabine (100mg/ml) > 240 minutes
4)Doxorubicin Hydrochloride (2 mg/ml) > 240 minutes
S)Etoposide (20mg/ml) > 240 minutes
6)Fluorouracil (50mg/ml) > 240 minutes
7)Methorexate (25mg/ml) > 240 minutes
8) Paclitaxel (6mg/ml) > 240 minutes
9) Thiotepa (10mg/ml) ' 67.8 minutes
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time :
Carmustine (BCNU) (3.3mg/ml)
Thiotepa (10mg/ml)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141623: Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141623
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026